Evaluating the Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Concerns in … (NCT07554950) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluating the Impact of Psychoeducation and Sleep-informed Workshop Targeting Sleep Concerns in Women and Individuals With Premenstrual Dysphoric Disorder
Canada72 participantsStarted 2026-06
Plain-language summary
Premenstrual Dysphoric Disorder (PMDD) is a cyclical mood disorder characterized by emotional, cognitive, physical, and sleep-related symptoms that occur in the days leading up to menstruation and improve shortly after menstruation begins. Although medications are commonly used to treat PMDD, many individuals experience side effects, do not benefit from medication, or prefer non-medication-based approaches. Sleep difficulties are very common in individuals with PMDD and may contribute to mood symptoms, emotional regulation difficulties, and functional impairment. Psychological interventions that focus on sleep, such as sleep psychoeducation and cognitive-behavioural strategies for insomnia, are effective in other mood and anxiety disorders but have not been well studied in PMDD. This study aims to evaluate the feasibility, acceptability, and preliminary effects of a brief, sleep-focused psychoeducation workshop tailored for individuals with PMDD or severe premenstrual symptoms. Information collected in this study may help inform future research and may improve care for individuals with PMDD.
Who can participate
Age range
16 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 16 and above
. positive screening for severe PMS and PMDD as per the Premenstrual Severity Screening Tool (PSST)
. experiencing sleep difficulties captured by a score of 12 or greater on the Insomnia Severity Index (ISI)
. reported regular menstrual cycle (average length of 25-35 days)
. not taking psychoactive medication or oral contraceptives or a) participants must be on a stable in dose and type for at least 8 weeks prior to the start of the study and b) medications remain stable throughout the study
. fluent in English, minimal grade 8 reading level to understand written materials
. individuals must have access to a smart phone or tablet with stable internet connection in order to complete study daily questionnaires
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Insomnia Severity Index (ISI)
Timeframe: Throughout the duration of the study (60 days), change will be assessed weekly.
2
Actigraphy watches
Timeframe: Actigraphy watches will be worn daily for 60 days for all participants.